Why The PolyPid Stock Increased 10.2% (PYPD)

By Amit Chowdhry ● Jan 25, 2023
  • The stock price of PolyPid (PYPD) increased by 10.2% in the most recent trading session. This is why.

The stock price of PolyPid (PYPD) increased by 10.2% in the most recent trading session.

Why: PolyPid provided a positive regulatory update for D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs). And following a recent type D meeting communication with the U.S. Food and Drug Administration (FDA) on the SHIELD I Phase 3 data, the Company now has clarity regarding the regulatory pathway toward a potential New Drug Application (NDA) submission.

PolyPid provided the FDA with currently available data from the SHIELD I study evaluating D-PLEX100 for the prevention of abdominal colorectal SSIs. And based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission.

The FDA stated that the ongoing SHIELD II study, which to date has enrolled more than 200 patients, could potentially serve as such a study. And PolyPid is now working expeditiously to finalize the design of the revised SHIELD II trial and expects to resume patient recruitment next quarter.

KEY QUOTE:

“We are pleased with the outcome of our recent interactions with the FDA and are grateful to the Agency for their supportive feedback. We now have a clear regulatory pathway for the possible approval of D-PLEX100 in United States, and we remain highly confident in the potential of our promising late-stage product candidate. We are focused on evaluating the most appropriate measures to implement the FDA’s recommendations and are also preparing for near-term interactions with the EU regulatory authorities regarding D-PLEX100. We look forward to providing further clinical and regulatory updates on both U.S. and European markets.”

  • Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer